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Efficacy and Safety of Biocellulose Sheet Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment

This study has been completed.
Agricultural Research Development Agency (Public Organization)
Information provided by (Responsible Party):
Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University Identifier:
First received: March 5, 2013
Last updated: March 10, 2015
Last verified: March 2015
The laser areas treated with biocellulose sheet from coconut juice containing anti-hyperpigmentation agent ("biocellulose mask", "Farhorm®") heal faster than vaseline ointment which is a standard treatment.

Condition Intervention
Skin Pigmentation
Skin Irritation
Device: "Biocellulose Mask", Farhorm®"

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Biocellulose Sheet From Coconut Juice Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • The skin pigmentation immediately after laser therapy and after using biocellulose mask [ Time Frame: Change from immediately after laser treatment and 30 min after laser and treatment with mask ]

Enrollment: 30
Study Start Date: September 2012
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Detailed Description:
Volar surface at upper arm (2X2 cm) on both sides were treated with semi ablative, 1,550 nm Erbium: glass fractional laser. Biocellulose sheet from coconut juice containing anti-hyperpigmentation agent ("biocellulose mask","Farhorm®")was applied for 20 min on one side and the other side was treated with vaseline ointment. The redness, skin hydration and skin pigmentation were evaluated at that area before laser, immediately after laser and after applying the treatment. These parameters were compared between treatment (area treated with Biocellulose sheet from coconut juice containing anti-hyperpigmentation agent, "biocellulose mask", "Farhorm®") and control (vaseline ointment).

Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 20-50 years old
  • No skin problem such as inflammation, fresh wounds
  • Not receive laser treatment during last 3 months
  • No history of smoking or alcohol drinking
  • No allergy to licorice extract, Vit C, Vit E, arbutin or stearyl glycyrrhetinate
  • Willing to participate in this study and can comply with study protocol

Exclusion Criteria:

  • Has history of hyperallergic reaction
  • Has wound(s) on face during last 4 weeks
  • Has history of eczema, psoriasis during last 6 months
  • Has laser treatment during last month
  • Use steroid, antibiotic, anti-inflammatory drugs or antihistamine during 3 days before recruiting
  • Had major surgery during last 12 months
  • Has history of cancer during last 12 months
  • Pregnant or lactation
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Please refer to this study by its identifier: NCT01806831

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Bangkok, Thailand, 10310
Sponsors and Collaborators
Chulalongkorn University
Agricultural Research Development Agency (Public Organization)
  More Information

Responsible Party: Pornanong Aramwit, Pharm.D., Ph.D, Associate Professor, Chulalongkorn University Identifier: NCT01806831     History of Changes
Other Study ID Numbers: CU 12-33-009
Study First Received: March 5, 2013
Last Updated: March 10, 2015

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases processed this record on April 24, 2017